DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED is an FDA 510(k)-cleared medical device (K914602) manufactured by The Heart Valve Div. Medtronic Cardiovascular Surg. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1991. Regulation: 8.